In the Matter of the Complaint Against THE ROBERTSON-TAYLOR COMPANY Suite 290 781 W. Oakland Park Boulevard at Fort Lauderdale, FL 33311-1729 at 135 E. Oakland Park Blvd. and at 129 East Oakland Park Boulevard Fort Lauderdale, FL 33334-1153 P.S. Docket No. 16/102; 10/28/83 Grant, Quentin E. APPEARANCE FOR COMPLAINANT: Hilda Rosenberg, Esq. Consumer Protection Division Law Department United States Postal Service Washington, DC 20260-1100 APPEARANCE FOR RESPONDENT: Lee H. Harter, Esq.2256 Van Ness Avenue
San Francisco, CA 94109-2513
In Complaints filed with this office Complainant alleges that Respondent is in violation of 39 U.S.C. § 3005 in seeking remittances of money through the mail by means of false representations concerning the products involved in these proceedings. The specific false representations alleged are set forth in the findings of fact below.
Respondent's answers to the Complaints deny substantially all the allegations in the two Complaints.
On Respondent's motion the hearing location was changed to Fort Lauderdale, Florida, where these matters were heard, along with five other similar proceedings against Respondent, on July 19 - 22, 1983.
All proposed findings of fact, conclusions of law, and arguments submitted by the parties have been considered in arriving at these decisions. To the extent indicated they have been adopted. Otherwise, they have been rejected as irrelevant, immaterial, or contrary to the evidence.
Complainant's witnesses in these proceedings were Postal Inspector Gary D. Cantley and Dr. James K. Smolev.
Respondent's witnesses were Mitchell Kenneth Friedlander, President of Respondent, and Dr. John W. Gaul, an osteopathic physician.
1. Complainant's expert witness Dr. James K. Smolev is an Assistant Professor in the department of urology at Johns Hopkins University School of Medicine and is associated with the Sexual Behavior Consultation Unit at the University (Tr. 501, 503-504). He is also engaged in the private practice of urology in Baltimore, Maryland (Tr. 502).
About 10-20% of his patients are persons whom he treats for impotence (Tr. 502) and in the past year, alone, Dr. Smolev has worked with some 200 patients who suffer from sexual dysfunction, in general (Tr. 530).
The Sexual Behavior Consultation Unit with which he is associated and which refers patients to him (Tr. 503) has 1,000 patients in any one year (Tr. 522). The Hopkins clinic is a major referral center (Tr. 522) and the largest such clinic in the Baltimore area (Tr. 523). Patients who visit the clinic constitute a representative sampling of all persons having sexual dysfunction (Tr. 588). The clinic is composed of health professionals who specialize in the diagnosis and treatment of the entire spectrum of sexual dysfunction. These professionals include psychiatrists, psychologists, gynecologists, internists, social workers, and mental health workers (Tr. 504). Dr. Smolev consults with these other professionals about specific patients and with regard to seminars which the unit holds for educational purposes (Tr. 589).
Dr. Smolev contributed two chapters to "Clinical Management of Sexual Disorders," a book published this year by the staff of the Hopkins Clinic. The book discusses the treatment, classification, and diagnosis of all forms of sexual dysfunction (Tr. 505).
Dr. Smolev's professional duties in the department of urology include clinical and didactic lectures to medical students, interns, residents, nurses as well as other physicians (Tr. 502).
He also attends rounds on a weekly basis at the university's hospital and other area hospitals (Tr. 506).
The doctor lectures to both professional groups and non-professional groups in the area of sexual dysfunction.
Dr. Smolev is in charge of male services at Planned Parenthood of Maryland where he runs the vasectomy and fertility clinics and directs educational activities in such areas as sexual reproductive health and sexually transmitted disease (Tr. 505).
To keep current in the field of urology, in general, as well as in the area of sexual function, Dr. Smolev attends meetings of the four regional or national professional organizations to which he belongs (Tr. 506). He also subscribes to three scientific journals in the field of urology, the Journal of the American Medical Association, Fertility and Sterility and Medical Aspects of Human Sexuality (Tr. 505).
2. Respondent's expert witness, John W. Gaul, is an osteopathic physician who engages in general practice in Davie, Florida, with particular interest in preventive medicine and nutrition. He is a member of numerous osteopathic associations, the American Society of Orthomolecular Physicians, the International Academy of Metabology, and the American College of Applied Nutrition. He has a Ph.D. in nutrition (obtained in an off-campus program of about 1 1/2 years) from Donsback University, Huntington Beach, California.
3. Dr. Smolev was well-qualified to testify in these matters. His qualifications to testify were significantly superior to those of Dr. Gaul.
4. Respondent, The Robertson-Taylor Company, by means of advertisements and promotional materials appearing in generally circulated publications and sent through the mail to prospective customers seeks remittances of money or property through the mails for its product LIBUTOL 1500 at the addresses set forth in the caption hereof (Stip. at Tr. 11, 12; CX-1b - 19b, 21b, 22b - 25b, 27b; Admissions at G1, G3). Copies of typical advertisements are attached hereto as Exhibits A and B (CX-1b, 3b).
5. As alleged in the Complaint, Respondent's advertisements make the representations that Libutol-1500 is an effective sexual stimulant or aphrodisiac (Cplt. Par. III-1) and is effective in the treatment, alleviation, or cure of diminished sexual drive or desire or of loss of libido (Cplt. Par. III-2).
The whole tenor of Respondent's advertisements, as conveyed in the following language, encompasses these representations:
"When passion mixes with desire there is no holding back ... Finding a way to link physical passion with psychological desire has been the ancient unfulfilled dream of man. Today there is a formula that can satisfy this primordial urge - Libutol-1500. The precise blend that helps turn any time into the right time ...
Libutol can create those essential effects that lead to passion's ultimate climax ... Libutol can help release the hidden sexual desires in men and women. When inhibitions prevent you from realizing your deepest desires, Libutol-1500 breaks through the wall of tension and lets you enter the world of ultimate orgasmic experience ... Libutol is guaranteed to open the door to a new world of sexual arousal."
The heading of one ad - "FOR ADULTS ONLY" - and the warning in both major ads that the product "is only for the most sexually adventurous" strongly suggests the capacity of the product to produce the represented results.
6. Persons ordering the product receive it in a container with a label, the pertinent parts of which read as follows:
LIBUTOL-1500
Therapeutic Formulation
30 tablets
Adult Supplement
. . .
Ingredients:
100 mg Nicotinic Acid
20 mg. Ginsing
20 mg. Thea Sinensis
10 mg. Cinnamon
20 mg. ginger in a base of nutmeg and other
natural excipients
Dosage: Take 1 tablet as needed (You will feel the effects in approximately 15 minutes.) Restrict usage to once or twice a week. Effects will be cancelled if aspirin has been taken in prior 24 hours.
7. The ingestion of nicotinic acid, also known as niacin, will produce flushing of the face, a feeling of warmth, and some itching due to its efficacy as a vasodilator (Tr. 595, 596). Some people find these effects unpleasant (Tr. 597). The ingestion of thea sinensis (black tea), together with cinnamon, ginger, and nutmeg (flavoring agents), would be the equivalent of drinking a cup of tea which relaxes some people, and stimulates others because of the caffeine content of the tea (Tr. 598). The effects of the ingestion of ginsing are uncertain and, according to some studies, contradictory. For instance, there are reports of stimulative effects and depressive effects, vasodilation and vasoconstriction, but there are no solid, hard data on the physiological effects of ginsing in humans on which claims of therapeutic effects can be based (Tr. 598, 599).
8. Libutol 1500 is not, physiologically, a sexual stimulant or aphrodisiac (Tr. 464, 608). The product might have a sexually stimulating placebo effect on a person with low sexual desire (Tr. 608).
9. Problems of low sexual desire are generally psychogenic and must be treated psychotherapeutically. In females there can also be two sexual dysfunctions which result in lack of interest in sex. One, resulting from various physical conditions is called dispareunia, which is pain during intercourse. The other, generally psychogenic in origin, is called anorgasmia (failure to experience an orgasm). It is treated with behavior modification or more prolonged psychotherapy (Tr. 602-607).
10. Libutol will not have a curative effect on persons suffering from low sexual desire. At most it might have a placebo effect (Tr. 464-468).
11. There are no scientific studies which relate caffeine, niacin, or any of the other ingredients of Libutol 1500 to sexual response, nutritionally or otherwise (Tr. 464-468, 615, 619-623).
12. The opinions expressed by Dr. Smolev which support the foregoing findings on the lack of efficacy of Libutol 1500 are in accord with the consensus of the medical community (Tr. 609).
13. The representations made by Respondent concerning Libutol 1500, as found above, are materially false in fact.
14. Respondent, by means of advertisements appearing in generally circulated publications, seeks remittances of money or property through the mails for its product TESTOREX-35 at the following addresses:
781 W. Oakland Park Boulevard
Fort Lauderdale, Florida 33311
(CX-1f - 14f, 17f - 20f;
Admissions at F-1 and F-3)
135 E. Oakland Park Boulevard
Fort Lauderdale, Florida 33334
(Tr. 11; CX-22c, p. 5, CX-15f;
CX-23c, p. 5, CX-16f)
A copy of a typical advertisement (CX-1f) for the product is attached hereto as Exhibit C.
15. As alleged in the Complaint, Respondent's advertisements make the representations that ingestion of Testorex-35 will effectively treat, alleviate, or cure impotence or sexual dysfunction (par. III-1) and will cause a male to have improved sexual performance (par. III-2). These representations are found in the following language of the advertisement:
"Like many men I kept my problem to myself until a friend introduced me to a Pharmacist who solved his problem with TESTOREX-35. TESTOREX-35 made a tremendous difference."
. . .
WHY IS TESTOREX-35 THE ADULT MALE SUPPLEMENT
IMPORTANT TO YOU?
The powerful male hormone testosterone is responsible for most of your 'manly functions'".
. . .
"Medical science now agrees there are physical reasons for male impotence. Because today's stress-filled times can affect your sexual performance you must do something to help yourself.
Testorex-35 will help you. Testorex-35 will produce a marked difference for you..."
16. Respondent's advertisements, in the language quoted below, also make the representation that ingestion of testosterone is a medically accepted form of treatment for male impotence or sexual dysfunction:
"TESTOREX-35 CONTAINS SPECIALLY PROCESSED
MALE GLANDULAR MATERIAL"
...
"In many cultures around the world the male sex glands of certain animals are consumed to enhance stamina and potency for men who do not perform satisfactorily.
The above statement has a scientific explanation: The male sex gland produces testosterone (the powerful male hormone). Today modern medicine prescribes testosterone ... to men who do not produce enough testosterone on their own ... The Testorex-35 adult male supplement contains specially prepared glandular material ... The exclusive Testorex-35 formula contains an added supply of essential compounds a man needs for the production of testosterone ... Because today's stress-filled times can affect your sexual performance you must do something to help yourself. Testorex-35 will help you ..."
17. Persons ordering the product receive it in a container with a label the pertinent parts of which read as follows (CX-21f):
Ingredients:
Testicular Extract 10 mg. Zinc (sulfate) 25 mg.
Cyanocobalamine 12 mcg. Octocosanol 5 mcg.
D-Calcium Pantothenate 10 mg. Thea Sinesis 20 mg.
Niacin 10 mg. Vitamin A 5,000 IU
Vitamin C 60 mg. D Alpha tocopherol 10 CI
Folic Acid 400 mcg. Selenium (yeast) 10 mcg.
In a base of Ginseng, Bee Pollen, Lecithin, Lysine, Calcium Supplier, Magnesium Gluconate, Manganese Sulfate, Kelp, L Glutamine and Pituitary Gland extract.
Usage: Take 1 Micro Tablet daily as dietary supplement. DO NOT exceed 1 tablet in any 24 hour period.
18. Problems of erection and ejaculation are the most common problems in male sexual dysfunction (Tr. 511).
19. Impotence is inability to obtain or sustain an erection for enough time to complete satisfaction of both partners in the sexual act (Tr. 502). Problems of erection may be organic or psychogenic or both (Tr. 513). Approximately 50% of impotence is organic and 50% psychogenic (Tr. 531). Organic impotence is caused, most commonly, by diabetes and medications taken for high blood pressure. Other causes include surgery and disorders of the blood vessels. The treatment of impotence depends on the cause (Tr. 515). If, for example, it is caused by medication for high blood pressure, that medication will be changed (Tr. 516). The most standard form of treatment for organic impotence is penile prosthesis, i.e., the implanting of an artificial rod inside the penis (Tr. 516).
Psychogenic impotence is treated using either psychotherapy or behavior modification techniques (Tr. 514). These treatments have a 60-70% success rate (Tr. 584).
Problems of ejaculation are 99% psychogenic and are treated by psychotherapeutic or behavior modification therapies (Tr. 512). There are two major behavior therapies designed for treating premature ejaculation, whose purpose is to make the man aware of the body sensations which occur right before ejaculation so that he can delay it (Tr. 512). Behavior therapy techniques for treating premature ejaculation are 80% successful (Tr. 584).
20. Deficiencies in vitamins or minerals are not generally considered causes of sexual dysfunction (Tr. 518). A person suffering from malnutrition would be too weak to even think about sexual performance (Tr. 561). Vitamins are not part of a therapy approach to sexual dysfunction (Tr. 539) because there is no proof of their effectiveness for these conditions (Tr. 542). Nutritional approaches to sexual dysfunction are not mentioned in the literature Dr. Smolev reads (Tr. 537) nor is Testorex-35 specifically referred to in the medical literature (Tr. 552).
21. A discussion of zinc (which appears in Testorex as zinc sulfate) has appeared in the medical literature in relation to sperm counts, infertility, and the prostate gland (Tr. 552) but is not related to sexual dysfunction except for some studies that have suggested that zinc put in the dialysis bath may improve impotence experienced by uremics. However, zinc is not generally accepted in the medical community as a treatment for impotence in uremics. Uremics make up less than 1% of all impotent men (Tr. 519).
22. Testorex-35 will not treat, alleviate or cure sexual dysfunction for the average adult male suffering from that condition (Tr. 519). Testorex-35 will not treat, alleviate or cure the two most common problems of male sexual functioning--problems of ejaculation and problems of erection, also known as impotence (Tr. 511, 513, 517, 585).
23. Testosterone is prescribed by the informed medical community only to persons who have low testosterone levels. It is not generally prescribed to persons who suffer from impotence or sexual dysfunction, unless they have documented low testosterone levels. Only 3% of all men with sexual functioning problems have low testosterone levels (Tr. 519, 520).
24. The findings above concerning the lack of efficacy of the product are based on the testimony of Complainant's expert witness, Dr. Smolev. His views are in accord with consensus of the informed medical community (Tr. 520, 521).
25. Respondent's representations that Testorex-35 will effectively treat, alleviate or cure impotence or sexual dysfunction for the average adult male and will cause a male to have improved sexual performance are false in fact. Based on testimony of both medical experts that testosterone is used as treatment in some cases of male impotence or sexual dysfunction, Complainant has failed to sustain its burden of proof as to the falsity of the representation alleged in paragraph III-3 of the Complaint.
1. The meaning of advertising representations is to be judged from a consideration of an advertisement in its totality and the impression it would most probably create in ordinary minds. Donaldson v. Read Magazine, 333 U.S. 178 (1948); Vibra-Brush Corp. v. Schaffer, 152 F. Supp. 461 (S.D.N.Y. 1957); Borg-Johnson Electronics v. Christenberry, 169 F. Supp. 746 (S.D.N.Y. 1959). Express representations are not required. It is the net impression which the advertisement is likely to make upon purchasers to whom it is directed which is important, and even if an advertisement is so worded as not to make an express representation, if it is artfully designed to mislead those responding to it the mail fraud statutes are applicable. G. J. Howard v. Cassidy, 162 F. Supp. 568. See, also, Virginia State Board of Pharmacy v. Virginia Citizens Council, 425 U.S. 748 (1976). The foregoing principles of interpretation were employed in arriving at the findings of representations made by Respondent concerning the products involved in these proceedings.
2. Although informed persons may readily recognize that Respondent's advertising claims are false and absurd, this does not detract from their tendency to "deceive the ignorant, gullible and less experienced." Gottlieb v. Schaffer, 141 F. Supp. 7, 16 (S.D.N.Y. 1956). The false representation statute was intended to protect such persons as well. Donaldson v. Read Magazine, Inc., supra.
3. A descriptive product name is itself a representation of the qualities of the product. Slumber-Shapers, Inc., P.S. Docket No. 2/20, Postal Service Decision (1973). The name Testorex in the context of Respondent's advertisement which places much stress on the use of testosterone in treating male sexual dysfunction is such a name.
4. Evidence, other than Respondent's advertisements and other promotional materials, on the issue of the making of the representations charged in the Complaint is unnecessary. Manuel Garcia Imports, P.S. Docket No. 5/127, Postal Service Decision at p. 5 (1977); Beauty Originals, Inc., P.S. Docket No. 3/24, Postal Service Decision at p. 3 (1975) (" T he cases are legion in which the trier of fact is called upon to apply the test of Donaldson v. Read, 333 U.S. 178, without resort to lay testimony.")
5. The average person reading Respondent's advertisements would interpret them substantially as characterized in the complaints as amended.
6. An expert witness may rely on the product label in forming his opinion on the veracity of the advertising claims made for the product. No chemical analysis is required. Vitahair, P.S. Docket No. 7/76, Initial Decision (1978); Derma-Diet, P.S. Docket No. 5/171, Postal Service Decision (1977). The product label may be assumed to be correct, unless Respondent comes forward with evidence that there are additional ingredients in the product. Schiffahrts Laboratories, P.S. Docket No. 3/193, Initial Decision (1976). Respondent did not produce such evidence.
7. Expert opinion testimony need not be based upon tests of the particular product to constitute sufficient evidence of false advertising. Reilly v. Pinkus, 338 U.S. 269, 274 (1949); Original Cosmetics Products, Inc. v. Strachan, 459 F. Supp. 496 (S.D.N.Y. 1978), aff'd, 603 F.2d 214 (2d Cir. 1979), cert. denied, 444 U.S. 195 (1979); Athena Products Ltd., P.S. Docket No. 12/136, Decision on Motions and Initial Decision at p. 30 (August 13, 1982) aff'd, Postal Service Decision (May 16, 1983).
8. The existence of a money back guarantee does not preclude a finding that the postal misrepresentation statute has been violated because a promise of guarantee will not dispel Respondent's false representations. Borg-Johnson Electronics, Inc. v. Christenberry, 169 F. Supp. 746, 751 (S.D.N.Y. 1959); G. J. Howard v. Cassidy, 162 F. Supp. 568, 572 (E.D.N.Y. 1958); Farley v. Heininger, 105 F.2d 79, 84 (D.C. Cir. 1939); George M. Ernst, Jr. d/b/a Many Interested Savers, Inc., P.S. Docket No. 13/88, Postal Service Decision (August 4, 1982).
9. Respondent's strong suggestion in examination of both medical experts that the products may have a placebo effect is irrelevant. It has been held repeatedly that it is no defense to a false representation proceeding that a product may have a placebo effect. See, for example, Wilmont Products, P.S. Docket No. 6/46 (PSD 1979).
10. The representations made by Respondent concerning the products involved in these proceedings, as found above, except for that alleged in paragraph III-3 of the Complaint, are materially false in fact.
11. Complainant has established its case in these proceedings by a preponderance of the reliable and probative evidence of record.
12. Respondent is engaged in the conduct of schemes for obtaining money or property through the mails by means of materially false representations concerning the products involved in these proceedings in violation of 39 U.S.C. § 3005.
13. Orders in the form attached should be issued against Respondent.